May 19, 2011— The Health Resources and Services Administration (HRSA) this morning made available for public inspection a long-awaited proposed regulation to implement health care reform's prohibition on 340B discounts for orphan drugs purchased by hospitals that became eligible for the program under reform. The proposed regulation, which is the first ever for the 340B … [Read more...]
OMB Completes Its Review of 340B Orphan Drug Rules
New patient definition guidance could be issued any day now.May 17, 2011— The White House Office of Management and Budget (OMB) has finished reviewing proposed federal regulations to implement health care reform's partial prohibition on 340B discounts for orphan drugs. On its Web site late yesterday, the budget agency noted that it sent the draft back to the Health Resources and Services Administration (HRSA) with unspecified … [Read more...]
Studies: Medicaid Block Grants Would Fuel Uncompensated Care
Reports released as negotiations that will decide OPA's funding heat up.May 13, 2011— U.S. House Republican proposals to repeal health care reform and convert Medicaid into a block grant could add up to 44 million people to the ranks of the uninsured by 2021, a new study this week by the nonpartisan Kaiser Commission on Medicaid and the Uninsured concludes. The U.S. Department of Health and Human Services (HHS), meanwhile, reported on the same … [Read more...]
Pace of Rural, Children’s and Cancer Hospital Enrollment in 340B Falls
Number of sites added in April down 50 percent from January's figure.May 11, 2011— The Office of Pharmacy Affairs (OPA) added 150 rural, children's and cancer hospital sites to its 340B covered entity database on April 1—a 50 percent decline from the number added at the start of the previous quarter. Two hundred ninety three rural, children's and cancer hospital sites were added to the database on Jan. 1. Another 599 were added during August … [Read more...]
FTC Staff Approves IVIG Producers’ Merger
Grifols' purchase of Talecris will diminish access at 340B pricing, providers say.May 9, 2011— The intravenous immunoglobulin (IVIG) manufacturers Grifols and Talecris have signed a consent agreement with the Federal Trade Commission's (FTC) staff setting the conditions for their proposed merger—a development that 340B covered entities believe will further limit their access to IVIG and the related product albumin at 340B prices. The two companies made … [Read more...]
OMB Clears 340B Patient-Definition Notice for Publication
Guidance document will have a major impact on the program.May 5, 2011— The White House Office of Management and Budget (OMB) has finished reviewing an important draft guidance document that will redefine the term "patient" for purposes of 340B drug discounts. Now that it has been cleared, the Health Resources and Services Administration (HRSA) could publish it in the Federal Register at any time. At the same time as it issues the … [Read more...]
CMS Updates Part D and Medicare Advantage Regulations
Rule implements health care reform provision to close the "donut hole".May 5, 2011— The Centers for Medicare and Medicaid Services (CMS) has updated its regulations for the Medicare Advantage and Medicare Prescription Drug Benefit Programs for contact year 2012. The final rule implements many provisions of the Affordable Care Act, such as closing the Part D "donut hole" for Medicare beneficiaries. Under the rule, beginning this year … [Read more...]